Riverpoint Medical 18G Brachy Grid: Not EU Approved - Recall
Riverpoint Medical recalls 18G Brachy Grid (RPG-18) due to lack of EU approval. This device is used in brachytherapy procedures but is not approved for sale in the European Union.
Recall notice
Product is labeled with "CE", but is not yet approved in the European Union.
Contact the company
What happened, in plain English
Riverpoint Medical is recalling its 18G Brach: Grid B&K style (RPG-18) because it is labeled with 'CE' but not approved in the European Union. This means the product is not legally allowed for sale in the EU, though it may still be used in other regions. Read more at govinfonow.com/recall/72159-riverpoint-medical-18g-brachy-grid-not-eu-approved-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/72159-riverpoint-medical-18g-brachy-grid-not-eu-approved-recall · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0777-2019
Cite this page
“Riverpoint Medical 18G Brachy Grid: Not EU Approved - Recall.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72159-riverpoint-medical-18g-brachy-grid-not-eu-approved-recall. Based on FDA recall #Z-0777-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0777-2019%22&limit=1).
Why it’s dangerous
The product is labeled with 'CE' (indicating it meets European safety standards) but has not been approved for sale in the European Union. This means it may not meet EU regulatory requirements, potentially leading to safety issues if used in EU facilities.
Who’s affected
Patients and medical professionals who use this brachytherapy grid in procedures within the European Union are affected. Those outside the EU may not be at risk as the product is not intended for EU markets.
How to tell if you have this one
Check for the model number RPG-18 on the product. The lot numbers 18061816 and 18101521 are associated with this recall. The product is used in brachytherapy procedures to assist with precise needle placement.
- Brand
Riverpoint Medical- Category
Medical device
What to do — step by step
Check Product Details
Look for the model number RPG-18 and lot numbers 18061816 or 18101521 on the device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide Distribution in the states of IL, WA, and FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Illinois, Washington.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0777-2019 (January 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0777-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.